ON November 14, 2023 Calidi Biotherapeutics, Inc. (NYSE American: CLDI or "Calidi"), a clinical-stage biotechnology company developing a new generation of targeted immunotherapies, reported its financial results for the third quarter 2023 and reviews recent business highlights (Press release, Calidi Biotherapeutics, NOV 14, 2023, View Source [SID1234637672]).
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"We are highly encouraged by our clinical progress, highlighted by our partner City of Hope dosing the first patient in June this year in a Phase 1 clinical trial evaluating CLD-101, our NeuroNova platform, in high-grade glioma patients," said Allan Camaisa, CEO and Chairman of the Board of Calidi Biotherapeutics. "Our CLD-201 program, which we believe represents the future of immunotherapy as a novel allogeneic approach, continues to advance closer to the clinic, supported by promising preclinical data presented at the 2023 SITC (Free SITC Whitepaper) annual meeting. With access to the public markets and recent key leadership and Board appointments, we feel well positioned to deliver on the promise of our novel programs and look forward to sharing interim results from our ongoing CLD-101 study in recurrent high-grade glioma patients in the first half of next year."
Third Quarter 2023 and Recent Corporate Developments
Presented updated CLD-201 (SuperNova) data demonstrating inhibition of tumor growth and the induction of robust anti-tumor immunity in preclinical models at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 38th Annual Meeting. The poster presentation exhibited CLD-201’s greater resistance to inactivation compared to unprotected CAL1 virus, significant inhibition of the growth of tumors even at very low doses, and the induction of robust anti-tumor immunity. The poster also detailed the clinical readiness of the product and plans to launch a Phase 1 study in 2024.
Appointed Andrew Jackson to the role of Chief Financial Officer. Mr. Jackson most recently served as Chief Financial Officer of Eterna Therapeutics and brings 25 years of corporate finance experience with success in publicly traded life science companies and venture capital-backed startups. The company also announced the appointment of Alan Stewart, previously a Calidi advisor, to the Board of Directors. Mr. Stewart brings extensive experience in finance and public company governance.
Closed business combination transaction and commenced trading on the NYSE American on September 13, 2023. In conjunction with the transaction closing, Calidi entered into a forward purchase agreement with a consortium of funds for up to $10 million.
Announced City of Hope, in partnership with Calidi, dosed the first patient in June 2023 in a Phase 1 clinical trial evaluating CLD-101 (NeuroNova) for the treatment of recurrent high-grade gliomas. The trial seeks to determine the safety, immunogenicity, and preliminary clinical efficacy of treatment with multiple intracerebral doses of CLD-101.
Upcoming Anticipated Milestones
4Q 2023: First patient dosed in CLD-101 Phase 1 trial in collaboration with Northwestern University for newly diagnosed high-grade glioma patients
1H 2024: Interim clinical results from CLD-101 Phase 1 trial in collaboration with City of Hope for recurrent high-grade glioma patients
1H 2024: First patient dosed in CLD-201 Phase 1 trial
Third Quarter Financial Results
The company reported a net loss of $2.0 million, or $0.14 per share, for the three months ended September 30, 2023, compared to a net loss of $5.4 million, or $0.63 per share, for the same period in 2022.
Research and development expenses were $3.3 million for the three months ended September 30, 2023, compared to $1.9 million for the comparable period in 2022, an increase of $1.4 million. The increase in research and development spend primarily reflects an increase in lab expenses for preclinical and clinical candidates of $0.7 million, an increase in salaries and benefits due to higher headcount of $0.5 million, and an increase in rent expense related to the San Diego Lease of $0.2 million.
General and administrative expenses were $4.0 million for the three months ended September 30, 2023, compared to $5.0 million for the comparable period in 2022, a decrease of $1.0 million. The decrease was primarily related to a decrease in transaction costs of $1.8 million, partially offset by an increase in salaries and benefits of $0.5 million, director and consulting costs of $0.2 million, and accounting related services of $0.1 million.
The company had approximately $10.1 million in cash and $0.2 million in restricted cash as of September 30, 2023, compared to $0.4 million in cash and $0.2 million in restricted cash as of December 31, 2022.